CROSSCHECK PLATING SYSTEM— 510(k) K132594

Clearance details

Applicant

Solana Surgical, LLC

Product code

Code HRS

Device class

Class 2

Regulation

21 CFR 888.3030

Advisory panel

Orthopedic

Date received

2013-08-19

Decision date

2013-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Memphis, TN, US

• K262098 — EnHAnce PEEK Bunion System2026-09-18
• K262963 — TMC Implant Fixation System2026-09-15
• K261647 — Tempo Plating System; Ultra Compression Screw System2026-09-03
• K261830 — FRAXION 3.5 Plate System (Various - See Catalog) +3 more2026-08-28
• K262537 — Versalock Sterile Plating System2026-08-19

• K131187 — LESSER METATARSAL HEAD IMPLANT SYSTEM2013-10-22
• K124045 — FUSEFORCE IMPLANT SYSTEM2013-07-10
• K122738 — GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET2012-11-07
• K120390 — SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET2012-04-10
• K113752 — METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET2012-02-06

Death

27

Injury

10,340

Malfunction

3,328

Total

13,695

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2541-2015 — CrossCHECK Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-L3008; 3.0 x 10 mm, REF CCP-L3010; 3.0 x 12 mm, REF CCP-L3012; 3.0 x 14 mm, REF CCP-L3014; 3.0 x 16 mm, REF CCP-L3016; 3.0 x 18 mm, REF CCP-L3018; 3.0 x 20 mm, REF CCP-L3020; 3.0 x 22 mm, REF CCP-L3022; 3.0 x 24 mm, REF CCP-L3024; 3.0 x 26 mm, REF CCP-L3026; 3.0 x 28 mm, REF CCP-L3028; 3.0 x 30 mm, REF CCP-L3030; 3.0 x 32 mm, REF CCP-L3032; 3.0 x 34mm, REF CCP-L3034; 3.0 x 36 mm, REF CCP-L3036; 3.0 x 38 mm, REF CCP-L3038; 3.0 x 40 mm, REF CCP-L3040; 3.5 x 8 mm, REF CCP-L3508; 3.5 x 10 mm, REF CCP-L3510; 3.5 x 12 mm, REF CCP-L3512; 3.5 x 14mm, REF CCP-L3514; 3.5 x 16 mm, REF CCP-L3516; 3.5 x 18 mm, REF CCP-L3518; 3.5 x 20 mm, REF CCP-L3520; 3.5 x 22 mm, REF CCP-L3522; 3.5 x 24 mm, REF CCP-L3524; 3.5 x 26 mm, REF CCP-L3526; 3.5 x 28 mm, REF CCP-L3528; 3.5 x 30 mm, REF CCP-L3530; 3.5 x 35 mm, REF CCP-L3532; 3.5 x 34 mm, REF CCP-L3534; 3.5 x 36 mm, REF CCP-L3536; 3.5 x 38 mm, REF CCP-L3538; 3.5 x 40 mm, REF CCP-L3540 The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.Class II·Terminated·Wright Medical Technology, Inc.·20150721
• Z-2542-2015 — CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N3008; 3.0 x 10 mm, REF CCP-N3010; 3.0 x 12 mm, REF CCP-N3012; 3.0 x 14 mm, REF CCP-N3014l; 3.0 x 16 mm, REF CCP-N3016; 3.0 x 18 mm, REF CCP-N3018; 3.0 x 20 mm, REF CCP-N3020; 3.0 x 22 mm, REF CCP-N3022; 3.0 x 24 mm, REF CCP-N3024; 3.0 x 26 mm, REF CCP-N3026; 3.0 x 28 mm, REF CCP-N3028; 3.0 x 30 mm, REF CCP-N3030; 3.0 x 32 mm, REF CCP-N3032; 3.0 x 34 mm, REF CCP-N3034; 3.0 x 36 mm, REF CCP-N3036; 3.0 x 38 mm, REF CCP-N3038; 3.0 x 40 mm, REF CCP-N3040; 3.5 x 8 mm, REF CCP-N3508; 3.5 x 10 mm, REF CCP-N3510; 3.5 x 12 mm, REF CCP-N3512; 3.5 14 mm, REF CCP-N3514; 3.5 x 16 mm, REF CCP-N3516; 3.5 x 18 mm, REF CCP-N3518; 3.5 x 20 mm, REF CCP-N3520; 3.5 x 22 mm, REF CCP-N3522; 3.5 x 24 mm, REF CCP-N3524; 3.5 x 26 mm, REF CCP-N3526; 3.5 x 28 mm, REF CCP-N3528; 3.5 x 30 mm, REF CCP-N3530; 3.5 x 32 mm, REF CCP-N3532; 3.5 x 34 mm, REF CCP-N3534; 3.5 x 36 mm, REF CCP-N3536; 3.5 x 38 mm, REF CCP-N3538; 3.5 x 40 mm, REF CCP-N3540. The CROSSCHECK Plating System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones in the hand, feet wrist and ankles, fingers and toes. The system may be used in both pediatric and adult patients. The device is intended for single use.Class II·Terminated·Wright Medical Technology, Inc.·20150721
• Z-1482-2015 — CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Left, REF CCP-HSX1L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1483-2015 — CROSSCHECK(R) Plating system, HOCKEY STICK CX Plate, Right, REF CCP-HSX1R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1484-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Left, REF CCP-LPX0L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1485-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1486-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Left, REF CCP-LPX1L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1487-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 1mm Step, Right, REF CCP-LPX1R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1488-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1489-2015 — CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1490-2015 — CROSSCHECK(R) Plating system, MTP NX Plate, Left, Recon, REF CCP-MPN2L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1491-2015 — CROSSCHECK(R) Plating system, MTP NX Plate, Right, Recon, REF CCP-MPN2R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1492-2015 — CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1493-2015 — CROSSCHECK(R) Plating system, MTP CX Plate, Right, REF CCP-MPX1R. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1494-2015 — CROSSCHECK(R) Plating system, Utility Plate, 2-Hole, REF CCP-UTN2. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1495-2015 — CROSSCHECK(R) Plating system, Utility Plate, 3-Hole, REF CCP-UTN3. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1496-2015 — CROSSCHECK(R) Plating system, Utility Plate, 4-Hole, REF CCP-UTN4. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1497-2015 — CROSSCHECK(R) Plating system, Utility Plate, 5-Hole, REF CCP-UTN5. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1498-2015 — CROSSCHECK(R) Plating system, Utility Plate, 6-Hole, REF CCP-UTN6. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306
• Z-1499-2015 — CROSSCHECK(R) Plating system, Utility Plate, 7-Hole, REF CCP-UTN7. Orthopedic use.Class II·Terminated·Wright Medical Technology, Inc.·20150306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132594.